FDA Trials Data

General

Attempting to find raw large-scale data on all FDA trials

Part of Federal Grant Data

Clinical Trials

clinicaltrials.gov is a registry and results database for publicly and privately supported clinical studies globally.

Not limited to just completed trials with results and records can be downloaded in XML format.

Downloaded all US trials (and results in trials where available) as XML

Downloaded list of all trial records as CSV

In E:\McNair\Projects\FDA Trials

Can Narrow based on completion status using advanced search

study_fields file is a header file for the xml documents. Contains the fields listed below.

xml files in study records folder, example of such file contained below. Where applicable, the XML file also includes the results of the study.

Clinical trial data downloaded has every US trial that began after 1997 (mandatory record keeping as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA)), but there are trials from as early as 1985 in the dataset

List of Records

Contains:

• Rank
• NCT Number
• Title
• Recruitment
• Study Results
• Conditions
• Interventions
• Sponsor/Collaborators
• Gender
• Age
• Phases
  • indicates phase in FDA approval process, detailed in reference [1]
  • Phase 1-3 are pre-FDA approval, phase 0 is before FDA is involved and Phase 4 is post approval
• Enrollment
• Funded Bys
• Study Types
• Study Designs
• Other IDs
• First Received
• Start Date
• Completion Date
• Last Updated
• Last Verified
• Results First Received
• Acronym
• Primary Completion Date
• Outcome Measures
• URL

Example XML

<clinical_study rank="91460">
<required_header>
<download_date>
ClinicalTrials.gov processed this data on January 11, 2017
</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT00002322</url>
</required_header>
<id_info>
<org_study_id>210A</org_study_id>
<secondary_id>M/3330/0018</secondary_id>
<nct_id>NCT00002322</nct_id>
</id_info>
<brief_title>
A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
</brief_title>
<official_title>
Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
</official_title>
<sponsors>
<lead_sponsor>
<agency>Pharmacia and Upjohn</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>

NIH AIDS Clinical Trials Information Service

<oversight_info>
<authority>United States: Food and Drug Administration</authority>
</oversight_info>
<brief_summary>
<textblock>
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<study_design>
Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment
</study_design>
<condition>HIV Infections</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Atevirdine mesylate</intervention_name>
</intervention>
<intervention>...</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria Concurrent Medication: Allowed: - Primary or secondary prophylaxis for opportunistic infections. Patients must have: - HIV infection. - Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED: - Cryptococcosis - Pneumocystis carinii pneumonia - Herpes zoster - Histoplasmosis - CMV - Hepatic or renal disease - Lymphoma. - CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry. - Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry. - Consent of parent, guardian, or person with power of attorney if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - Intolerance to AZT. - Current diagnosis of malignancy for which systemic therapy will be required during the study. Concurrent Medication: Excluded: - Any other investigational drugs. Prior Medication: Excluded: - Cytotoxic chemotherapy within 1 month prior to study entry. - Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors. - Antiretroviral agents other than AZT within 3 months prior to study entry. Required: - AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>
Los Angeles County / Health Research Assoc / Drew Med Ctr
</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>...</location>
...
<location_countries>...</location_countries>
<verification_date>November 1996</verification_date>
<lastchanged_date>June 23, 2005</lastchanged_date>
<firstreceived_date>November 2, 1999</firstreceived_date>
<keyword>Drug Therapy, Combination</keyword>
<keyword>Acquired Immunodeficiency Syndrome</keyword>
<keyword>AIDS-Related Complex</keyword>
<keyword>Antiviral Agents</keyword>
<has_expanded_access>No</has_expanded_access>
<condition_browse>
<mesh_term>HIV Infections</mesh_term>
</condition_browse>
<intervention_browse>
<mesh_term>Zidovudine</mesh_term>
<mesh_term>Atevirdine</mesh_term>
</intervention_browse>
</clinical_study>